Health Condition 1: H521- Myopia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Children with myopia of SE between -0.50 D and -10.00 D (combination of -6.00DS and -4.00 DC) of age group 6-12 years 2) Documented history of myopia progression by more than - 0.50D and/or increase in axial length by more than 0.20mm between 6 months to one year while using 0.01% atropine once daily 3) Corrected VA is = 0.1 Log MAR or 0.8 in Snellen.
Exclusion criteria
Exclusion criteria: 1) Prior use of 0.01% low dose atropine twice a day 2) History of any previous myopia control intervention other than 0.01% low dose atropine 3) History of any ocular or systemic disease 4) History of any previous ocular surgery or trauma 5) Anisometropia > - 2.00 D; Astigmatism > - 1.50 D and Amblyopia 6) Any hypersensitivity/allergic reaction with use of 0.01% atropine 7) Myopia of higher than -8.00D (limited by availability of DIMS spectacle lens in power higher than that)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of myopia progression in terms spherical equivalent over 1 year of period.Timepoint: At baseline, 6 months and 1 year (total 18 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change in axial length and choroidal thickness over 18 months.Timepoint: At baseline, 6 months and 1 year (total 18 months) | — |
Countries
India
Contacts
Medical Research Foundation, Sankara Nethralaya